CALERIE (Tufts) - Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy

National Institutes of Health (NIH)

Status and phase

Completed

Phase 1

Conditions

Aging

Treatments

Behavioral: Caloric Restriction (CR)

Study type

Interventional

Funder types

NIH

Identifiers

NCT00099099

3U01AG020480 (U.S. NIH Grant/Contract)

AG0006

Details and patient eligibility

About

This study is one of three CALERIE trials that test the hypothesis that a reduced calorie, nutritionally sound diet increases the length of life and prevents some age-related chronic diseases such as cancer, diabetes, and cardiovascular disease. The three sites that are participating in the CALERIE trial represent a diversity of subject populations and interventional strategies.

Full description

Researchers at the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University are enrolling overweight men and women aged 20-42 in a 1-year study to develop an effective calorie restricted regimen that minimizes hunger and prevents weight regain. The study also examines the effects of weight loss on body composition, metabolism and aging. Two different diets containing usual foods and a healthy balance of nutrients will be tested at 2 levels of caloric restriction, 10% and 30% (in other words, 90% or 70% of what one would normally eat). Weight loss is expected for most volunteers participating in this study, but cannot be guaranteed.

Sex

All

Ages

25 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Healthy men and women
Body mass index (BMI) = 25-30
Slightly overweight, < 275 lbs
Women 25-45, pre-menopause
Men 25-50
Not traveling often or planning to move

Exclusions:

Cardiovascular disease or blood pressure greater than 160/90
Diabetes
Major psychiatric disorders
Eating disorders
Post obese; previous BMI > 32
Weight change of more than ten pounds in the past 90 days
Over 275 pounds
Smoking
Regular exercise, more than twice per week
Current prescription drug use, except oral contraceptives
Alcoholism or substance abuse
Pregnant or lactating (breast feeding), planning to become pregnant, or not regularly using contraception
Abnormal electrocardiogram (EKG)
Local resident for less than one year
Occupations requiring full alertness and motor skills, with no allowance for a chance of postural dizziness (airline pilots, etc.)
Injuries by any metallic object that is still present in the body
Braces, non-removable dentures, or non-removable bridgework